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510(k) K864491

SWANSON TITANIUM CARPAL LUNATE IMPLANT by Dow Corning Wright — Product Code KWN

K864491 is an FDA 510(k) premarket notification submitted by Dow Corning Wright for the device "SWANSON TITANIUM CARPAL LUNATE IMPLANT". The FDA issued a decision of Substantially Equivalent on April 15, 1987. The device falls under product code KWN (Prosthesis, Wrist, Carpal Lunate), a Class II device regulated under 21 CFR 888.3750. Dow Corning Wright has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 15, 1987
Date Received
November 13, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Wrist, Carpal Lunate
Device Class
Class II
Regulation Number
888.3750
Review Panel
OR
Submission Type

Other clearances by Dow Corning Wright

  • K932210 — ORTHOLOC ADVANTIM REVISION FEMORAL COMPONENT (September 7, 1994)
  • K932911 — ORTHOLOC ADVANTIM L.S. TIBIAL COMPONENT (June 30, 1994)
  • K934354 — LACEY ALL POLYETHYLENE TIBIAL COMPONENT (June 3, 1994)
  • K932222 — SLT FEMORAL HEAD (May 27, 1994)
  • K932858 — ORTHOLOC ADVANTIM TIBIAL BASE COMPONENT (February 16, 1994)
  • K930228 — ORTHOLOC ADVANTIM TIBIAL STEM 5 DEGREE (November 30, 1993)
  • K925900 — LACEY REVISION FEMORAL COMPONENT (August 24, 1993)
  • K930189 — ORTHOLOC(R) ADVANTIM(TM) POSTERIOR STAB FEMOR COMP (August 6, 1993)
  • K930188 — ORTHOLOC(R) ADVANTIM(TM) FEMORAL COMPONENT (August 3, 1993)
  • K930190 — ORTHOLOC(R) ADVANTIM(TM) NON-POR COAT FEMOR COMP (August 2, 1993)

Other clearances for product code KWN

  • K141920 — Wrist Hemiarthroplasty System (December 23, 2014)
  • K080997 — ASCENSION PYROCARBON LUNATE (June 17, 2008)
  • K050028 — MAESTRO CARPAL HEMIARTHROPLASTY (March 25, 2005)
  • K790793 — AMC R METACARPAL COMPONENT (June 22, 1979)

FDA data resources